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Multimodal Investigation of Cortico-Basal Ganglia-Thalamo-Cortical Network Dynamics in Dystonic Patients with Deep Brain Stimulation (DYScover)

F

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Status

Enrolling

Conditions

Dystonia

Treatments

Diagnostic Test: registration of local field potentials
Diagnostic Test: fMRI
Diagnostic Test: genetic panel
Diagnostic Test: EEG-MEG

Study type

Observational

Funder types

Other

Identifiers

NCT06716983
GR-2021-12375334 (Other Grant/Funding Number)
DYScover

Details and patient eligibility

About

The goal of this prospective open label study is to elucidate the pathophysiology of dystonia and to understand how deep brain stimulation (DBS) influences brain networks. The investigators will enroll patients with dystonia implanted with DBS of the Globus Pallidus internus (GPi) with sensing implantable neurostimulators, capable of measuring GPi local field potentials (LFPs).

The main questions it aims to answer are:

  • does DBS influence pallidal LFPs in the long term?
  • how the basal-ganglia-thalamo-cortical circuit is modified after DBS?
  • do LFPs changes correlate with clinical improvement? Participants will undergo to serial clinical evaluations, magnetoencephalography (MEG) and functional Magnetic Resonance Imaging (fMRI) studies. Primarily, the data obtained from our study might help in clarifying basic pathological electrophysiological features of dystonia. These features might be secondarily used in future to provide a framework for an effective application of closed-loop DBS in Dystonia.

Enrollment

15 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients diagnosed with idiopathic or genetic dystonia who have already undergone DBS surgery of the globus pallidus internus
  • Patient implanted with a neurostimulator capable of chronically recording LFPs and which is fully compatible with magnetic fields up to 3 Tesla.
  • Age>12 years

Exclusion criteria

  • Evidence of CNS pathology or any other acquired conditions (perinatal, infective, toxic, neoplastic, vascular, psychogenic) responsible for the dystonia phenomenology,
  • Focal distribution of dystonia
  • Contraindications to brain MRI or EEG/MEG
  • Adult subjects unable to express consent to inclusion in the study
  • Pregnancy, and breastfeeding.

Trial contacts and locations

1

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Central trial contact

Vincenzo Levi, M.D.; Nico Golfrè Andreasi, M.D.

Data sourced from clinicaltrials.gov

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